National Center for Clinical Laboratories and Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology , Beijing , China.
Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing , China.
Scand J Clin Lab Invest. 2019 Oct;79(6):404-411. doi: 10.1080/00365513.2019.1636404. Epub 2019 Jul 4.
The commutability of pooled patient sera (PPS) and control materials (CM) should be evaluated to investigate their suitability for use in an external quality assessment (EQA) program. Individual human samples, PPS and CM were analyzed by four routine methods and inductively coupled plasma mass spectrometry reference methods for magnesium and calcium measurements. The commutability was analyzed according to EP14-A3 protocol and the difference in bias approach, respectively. For magnesium measurements, all PPS were commutable and 3/5 CM were commutable for all measurement systems according to the EP14-A3 protocol. For calcium measurements, most PPS were commutable for all measurement systems, but the CM were only commutable with the Cobas c702 system. The IFCC approach produced similar commutability profiles, except that a large number of inconclusive results appeared. The routine methods exhibited excellent linearity and precision. The majority of relative biases between the routine and reference methods were beyond the bias limits. The commutability of the CM and PPS vary depending on which evaluation approach and criterion is applied. Superiority in the commutability of PPS over CM was observed whichever evaluation approach is applied.
应当评估汇集的患者血清（PPS）和对照品（CM）的互换性，以研究它们在外部质量评估（EQA）计划中的适用性。通过四种常规方法和镁和钙测量的电感耦合等离子体质谱参考方法分析个体人样本、PPS 和 CM。根据 EP14-A3 协议和偏差方法分别分析了互换性。对于镁测量，根据 EP14-A3 协议，所有 PPS 对于所有测量系统都是可互换的，并且 3/5 CM 对于所有测量系统都是可互换的。对于钙测量，大多数 PPS 对于所有测量系统都是可互换的，但 CM 仅与 Cobas c702 系统可互换。IFCC 方法产生了类似的可互换性分布，只是出现了大量不确定的结果。常规方法表现出优异的线性和精密度。常规方法和参考方法之间的大多数相对偏差超出了偏差限制。CM 和 PPS 的互换性因所应用的评估方法和标准而异。无论应用哪种评估方法，PPS 的互换性均优于 CM。
